Rx-to-OTC switches: trends and factors underlying success

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Abstract
Companies can decide to pursue switches from prescription (Rx) to over-the-counter (OTC) status for their drugs for various reasons, such as life-cycle management. Mahecha examines the rationale behind switches, the switch process and case studies of switches in the United States to understand the factors for success and anticipate future trends. The US Food and Drug Administration defines an Rx-to-OTC switch as over-the-counter (OTC) marketing of a drug product that was once a prescription (Rx) drug for the same indication, with the same strength, dose, duration of use, dosage form, population and route of administration. Here, we examine the rationale behind switches, the process of switches and historical case studies of switches in the United States to understand the factors for success and expected future trends.

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